Staccato Loxapine PK in Smokers and Nonsmokers

March 13, 2017 updated by: Alexza Pharmaceuticals, Inc.

Pharmacokinetics of Staccato® Loxapine for Inhalation in Smokers Compared to Nonsmokers

The objective of this trial was to assess the pharmacokinetics of a single dose of 10 mg Staccato Loxapine administered to smokers compared to nonsmokers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pharmacokinetics and sedation pharmacodynamics were studied using a visual analog scale were studied in male and female adult subjects (nonsmokers and smokers) following a single dose of 10 mg of inhaled loxapine. Blood samples were drawn at predose, 30 seconds, 1, 2, 3, 10, 30, and 60 minutes, and 2, 6, 12, and 24 hours after dosing. Loxapine and 8-OH-loxapine were analyzed using reverse-phase liquid chromatography coupled with a tandem mass spectrometer.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Covance Clinical Research Unit, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal spirometry at screening and in good general health as determined by a complete medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, and urinalysis,
  • Smokers must have a history of smoking > 15 cigarettes/day currently and for at least the last 2 years,
  • Nonsmokers must have never smoked > 5 cigarettes/day and not smoking at all for at least the last 2 years.

Exclusion Criteria:

  • Any acute illness in the 5 days,
  • Use of a bronchodilator for the treatment of wheezing within 12 months, OR
  • Any other disease or condition, by history, physical examination, or laboratory abnormalities that would present undue risk to the subject, or may confound the interpretation of study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy smokers
Healthy smokers, male and female
Drug: Inhaled Loxapine 10 mg
Staccato Loxapine 10 mg, single dose
Other Names:
  • Staccato Loxapine 10 mg
Experimental: Healthy nonsmokers
Healthy nonsmokers, Healthy smokers, male and female
Drug: Inhaled Loxapine 10 mg
Staccato Loxapine 10 mg, single dose
Other Names:
  • Staccato Loxapine 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Noncompartmental Pharmacokinetic parameters
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Vital signs
Time Frame: 24 hours
24 hours
Treatment emergent adverse events
Time Frame: 24 hours
24 hours
Sedation visual analog scale
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexza Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Randall R. Stoltz, MD, Covance Clincial Research Unit, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

April 1, 2009

First Submitted That Met QC Criteria

April 1, 2009

First Posted (Estimate)

April 2, 2009

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMDC-004-106
  • 27 February 2009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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